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The PILLAR SA Ti Spacer System when used with screws is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.

The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The The PILLAR SA Ti Interbody may be used as a standalone device only when at least two Screws are inserted with one inferior and one superior screw trajectory. If the surgeon chooses to use the PILLAR SA Ti Interbody with fewer than two Screws inserted with one inferior and one superior screw trajectory, then additional supplemental fixation system must be used. Hyperlordotic sizes (greater than 20°) are intended for use with supplemental fixation.

The PILLAR SA Ti Spacer System is an integrated in ody fusion device for use in anterior lumbar interbody fusion (ALIF) procedures. The PILLAR SA TI Spacer System is compised of 3D printed titanium interbody spacers with porous titanium end plates and a functional gradient porous structure, and bone screws. The implants are offered in multiple footprints and lordotic options to accommodate individual patient anatomy. Each porous interbody has a large central window for graft material and a threaded hole with a zero-step locking mechanism for screw retention.

The PILLAR SA TI Spacer System implants are provided sterile.

PILLAR SA TI Spacer System implants are designed to be used with PILLAR SA TI Spacer System instrumentation and are not compatible with components from any other manufacturer's system.

This is a 510(k) premarket notification for a medical device, specifically an intervertebral body fusion device. These types of notifications typically focus on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed clinical study with acceptance criteria for device performance in the same way a diagnostic AI/ML device would.

Therefore, the provided text does not contain the kind of information requested for AI/ML device studies (e.g., acceptance criteria for performance metrics like sensitivity/specificity, sample sizes for test sets, expert adjudication, MRMC studies, standalone performance, training set details).

Instead, the "acceptance criteria" for this device are related to its mechanical performance and substantial equivalence to existing devices. The study proving it meets these criteria is a non-clinical mechanical testing study.

Here's how to interpret the provided text in the context of your request:

1. A table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated as a number of "patients" or "cases." The "sample size" here refers to the number of test specimens (implants) subjected to mechanical testing. This information is typically detailed in the full mechanical test reports, which are not included in this summary.
• Data Provenance: Not applicable in the context of clinical data. This is mechanical test data, likely generated in a laboratory setting by the manufacturer (Orthofix, Inc.).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. Ground truth for mechanical testing is established by engineering standards and measurements, not clinical expert consensus. The "experts" would be the engineers and technicians performing the tests and analyzing the results according to the specified ASTM standards.

4. Adjudication method for the test set:

• Not applicable. This is mechanical testing against predefined engineering standards (ASTM F2077, F2267, F1877), not expert adjudication of clinical findings.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No. This is not an AI/ML device, and no MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• No. This is not an AI/ML device.

7. The type of ground truth used:

• Engineering Standards and Benchmarking: The "ground truth" for this device's performance is its ability to meet or exceed the mechanical performance characteristics of predicate devices, as evaluated according to industry standards (ASTM F2077, F2267, F1877).

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established:

• Not applicable. There is no "training set."

In summary, the provided document is a 510(k) summary for a traditional medical device (intervertebral fusion device), not an AI/ML device. Therefore, the performance evaluation focuses on mechanical testing and substantial equivalence rather than clinical performance metrics and studies typical for AI/ML diagnostic tools.

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When Used as a Cervical Intervertebral Body Fusion System:

The CONSTRUX Mini PEEK Spacer System is indicated for spinal fusion procedures at one or two contiguous levels within the cervical spine (C2-T1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.

The CONSTRUX Mini PEEK Spacer System is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation system; the hyperlordotic implants (≥10°) are required to be used with an anterior cervical plate.

Patients must have undergone a regimen of at least six weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PEEK Spacer System in the cervical spine.

When Used as a Partial Vertebral Body Replacement (VBR) System:

The CONSTRUX Mini PEEK Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectory) of a diseased vertebral body resected or excised for the treatment of turnors, to achieve anterior decompression of the spinal cord and to restore the height of a collapsed vertebral body. The CONSTRUX Mini PEEK Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. Lordotic implants greater than a 5° profile are not to be used for partial vertebral body replacement.

The CONSTRUX Mini PEEK Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. The Partial VBR Device is intended to be used with autograft or allograft and supplemental fixation system.

The CONSTRUX Mini PTC Spacer System is indicated for spinal fusion procedures at one or two contiguous levels within the cervical spine (C2-T1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.

The CONSTRUX Mini PTC Spacer System is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation system; the hyperlordotic implants (≥10°) are required to be used with an anterior cervical plate.

Patients must have undergone a regimen of at least six weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PTC Spacer System in the cervical spine.

The CONSTRUX Mini Ti Spacer System is indicated for spinal fusion procedures at one or two contiguous levels within the cervical spine (C2-T1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.

The CONSTRUX Mini Ti Spacer System is intended for use with autograft comprised of cancellous and/ or corticocancellous bone graft and supplemental fixation system; the hyperlordotic implants (≥10°) are required to be used with an anterior cervical plate.

Patients must have undergone a regimen of at least six weeks of non-operative treatment prior to being treated with the CONSTRUX Mini Ti Spacer System in the cervical spine.

The FORZA Spacer System is indicated for use with bone graft (autograft bone or allogenic bone graft composed of cancellous or corticocancellous bone graft) in patients with degenerative disk disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated.

The FORZA Spacer System is intended to be used with supplemental fixation systems. As an example, the supplemental fixation that may be used is the Orthofix Firebird Spinal Fixation System.

The FORZA Spacer System must be used with autograft or allogenic bone graft composed of cancellous or corticocancellous bone graft.

The FORZA PTC Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved levels.

The FORZA PTC Spacer System is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation, e.g., the Firebird Spinal Fixation System.

Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the FORZA PTC Spacer System.

The FORZA Ti Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved levels.

The FORZA Ti Spacer System is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation.

Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the FORZA Ti Spacer System.

The FORZA XP Expandable Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s).

The FORZA XP Expandable Spacer System is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft; and supplemental fixation system.

Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the FORZA XP Expandable Spacer System.

The LONESTAR Cervical Stand Alone System is indicated for spinal fusion procedures at one level in the cervical spine (C2-T1) in skeletally mature patients with degenerative disc disease (DDD), DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.

The LONESTAR Cervical Stand Alone System is used with autograft comprised of cancellous and/or corticocancellous bone graft and the two titanium alloy screws which accompany the implant.

Patients must have undergone a regimen of at least six weeks of non-operative treatment prior to being treated with the LONESTAR Cervical Stand Alone System in the cervical spine.

The PILLAR PEEK Spacer System is indicated for use with bone graft (autograft bone or allogenic bone graft composed of cancellous or corticocancellous bone graft) in patients with degenerative disk disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may have up to Grade I Spondylolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated.

The PILLAR PEEK Spacer System is intended to be used with supplemental fixation. As an example, the supplemental fixation that may be used is the Orthofix Spinal Fixation System (SFS).

The PILLAR PL PEEK Spacer is used singly or in pairs and is implanted using a posterior approach.

The PILLAR TL PEEK Spacer is used singly or in pairs and is implanted using a transforaminal approach.

The PILLAR AL PEEK Spacer is used singly and is implanted using an anterior approach.

The PILLAR XL PEEK Spacer is used singly and is implanted using a lateral approach.

The PILLAR PEEK Spacer System must be used with autograft or allogenic bone graft composed of cancellous or corticocancellous bone graft.

When used as a Partial Vertebral Body Replacement (VBR) Device:

The PILLAR PEEK Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The PILLAR Spacer System is also indicated for treating fractures of the thoracic and lumbar spine.

The PILLAR PEEK Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of a fusion for a prolonged period of time. The Partial VBR device is intended to be used with autograft or allograft.

The PILLAR PEEK Spacer System is intended for use with supplemental fixation. As an example, the supplemental fixation that may be used is the Orthofix Spinal Fixation System (SFS).

When used as an Intervertebral Body Fusion Device:

The PILLAR SA PEEK Spacer System is indicated for use with bone graft (autograft bone or allogenic bone graft composed of cancellous or corticocancellous bone graft) in patients with degenerative disk disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated.

The PILLAR SA PEEK Spacer System is intended for use with the four titanium alloy screws provided with the device. If the physician chooses to use fewer than four of the provided screws, then supplemental fixation must be used to augment stability. As an example, the supplemental fixation system that may be used is the Orthofix Firebird Spinal Fixation System.

The PILLAR SA PEEK Spacer System must be used with autograft or allogenic bone graft composed of cancellous or corticocancellous bone graft.

When used as a Partial Vertebral Body Replacement (VBR) Device:

The PILLAR SA PEEK Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The PILLAR SA PEEK Spacer System is also indicated for treating fractures of the thoracic and lumbar spine.

The PILLAR SA PEEK Spacer System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The PILLAR SA PEEK Spacer System is intended to be used with autograft or allograft.

The PILLAR SA PEEK Spacer System is intended for use with the four titanium alloy screws provided with the device. If the physician chooses to use fewer than four of the supplemental fixation must be used to augment stability. As an example, the supplemental fixation that may be used is the Orthofix Firebird System.

The PILLAR SA PTC Spacer System is indicated for spinal fusion procedures in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous nonfusion surgery at the involved level(s).

The PILLAR SA PTC Spacer System is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft.

The PILLAR SA PTC Spacer System is intended for use with four of the titanium alloy screws provided with the system. If the physician chooses to use fewer than four of the provided screws then supplemental fixation must be used to augment stability. As an example, a supplemental fixation system that may be used is the Orthofix Firebird® Spinal Fixation System.

Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the PILLAR SA PTC Spacer System.

When used as an intervertebral body fusion device, the SKYHAWK Lateral Interbody Fusion System is indicated for use with bone graft (autograft bone or allogenic bone graft composed of cancellous or corticocancellous bone graft) in patients with degenerative disk disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated.

The SKYHAWK Lateral Interbody Fusion System is intended to be used with supplemental fixation systems that are cleared by the FDA for use in the lumbar spine.

The SKYHAWK Lateral Interbody Fusion System must be used with autograft or allogenic bone graft composed of cancellous or corticocancellous bone graft.

CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System – The CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System is comprised of a variety of implants manufactured from PEEK (Polyetheretherketone), as described by ASTM F2026, with titanium markets as described by ASTM F67. The implants are available in multiple sizes to accommodate various patient anatomies. The superior and inferior surfaces of the implant have a pattern of ripples to provide increased stability and help prevent anterior/posterior movement of the device.

The CONSTRUX Mini PEEK VBR System is intended for vertebral body replacement to aid in the surqical correction and stabilization of the spine.

The CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System is not intended to be used as a stand-alone device and must be used with supplemental fixation. The implants are used singly and are implanted using an anterior approach.

The CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System implants are provided either in a sterile packaging configuration or non-sterile and requires sterilization prior to use.

CONSTRUX Mini PTC Spacer System - The CONSTRUX Mini PTC Spacer System is comprised of a variety of implants that have a PEEK core with integrated porous titanium end plates. CONSTRUX Mini PTC spacers are implanted in the cervical intervertebral disc space and are intended to facilitate vertebral fusion by stabilizing adjacent vertebrae, maintaining disc height and preventing the collapse of one vertebra onto another.

The CONSTRUX Mini PTC Spacer System is not intended to be used as a stand-alone device and must be used with supplemental fixation. The implants are used singly and are implanted using an anterior approach.

The CONSTRUX Mini PTC implants are provided sterile.

CONSTRUX Mini PTC implants are design to be used with CONSTRUX Mini PEEK Spacer System instrumentation. The CONSTRUX Mini PTC implants are not compatible with components or metal from any other manufacturer's system.

CONSTRUX Mini Ti Spacer System - The CONSTRUX Mini Ti Spacer System is comprised of a variety of 3D printed implants that have porous titanium end plates and a functional gradient porous structure. CONSTRUX Mini Ti spacers are implanted in the cervical intervertebral disc space and are intended to facilitate vertebral fusion by stabilizing adjacent vertebrae, maintaining disc height and preventing the collapse of one vertebra onto another.

The CONSTRUX Mini Ti Spacer System is not intended to be used as a stand-alone device and must be used with supplemental fixation. The implants are used singly and are implanted using an anterior approach.

The CONSTRUX Mini Ti implants are provided sterile.

CONSTRUX Mini Ti implants are design to be used with CONSTRUX Mini Spacer System instrumentation. The CONSTRUX Mini Ti implants are not compatible with components or metal from any other manufacturer's system.

FORZA PEEK Spacer System - The FORZA Spacer System consists of implants, trials and instruments. The system is comprised of a variety of implants fabricated and manufactured from polvetheretherketone (PEEK) as described by ASTM F2026 with tantalum markers as described by ASTM F560. PEEK is utilized due to its radiolucent properties, which aid the surgeon in determining if fusion in the operative site has occurred. Since PEEK is transparent in x-rays, tantalum marker pins are inserted into the implants in order to give surgeons a visual aid in determining the location of the implants both intraoperatively and postoperatively.

FORZA Spacer System implants are offered in two geometric shapes – straight and curved, and offered in parallel and lordotic profiles to restore the natural curvature of the implants can be used in single placement or in pairs. Both the curved and straight implants feature a bulleted nose for ease of insertion and anti-migration ripples on both the inferior and superior surfaces to provide increased stability and help prevent anterior/posterior movement of the device.

The FORZA Spacer System is intended for intervertebral body fusion to aid in the surgical correction and stabilization of the spine and are implanted using a posterior approach.

The FORZA Spacer System is not intended to be used as a stand-alone device. The FORZA Spacer System must be used with a supplemental fixation system. The implants are provided sterile but the instruments are provided non-sterilization prior to use.

FORZA PTC Spacer System - The FORZA PTC Spacer System is comprised of a variety of implants that have a PEEK (OPTIMA LT1) core with integrated porous titanium (Ti-6Al-4V) end plates as well as a tantalum marker that acts as a visual aid for the surgeon in determining the location of the implant both intraoperatively and postoperatively.

FORZA PTC Spacer System implants are offered in two geometric shapes - straight and curved, and offered in parallel and lordotic profiles to restore the natural curvature of the spine. The implants can be used in single placement or in pairs. Both the curved and straight implants feature a bulleted nose for ease of insertion and a roughened surface on both the inferior and superior faces of the implant to provide increased stability and help prevent anterior/posterior movement of the device.

The FORZA PTC Spacer System is intended for intervertebral body fusion to aid in the surgical correction of the spine and are implanted using a posterior approach.

The FORZA PTC Spacer System is not intended to be used as a standalone device. The FORZA PTC Spacer System must be used with a supplemental fixation system.

The FORZA PTC Spacer System implants are provided sterile.

FORZA PTC implants are designed for use with FORZA PEEK Spacer System instrumentation. The FORZA PTC spacers are not compatible with components or metal from any other manufacturer's system.

FORZA Ti Spacer System - The FORZA Ti Spacer System is comprised of a variety of 3D printed implants that have porous titanium end plates and a functional gradient porous structure.

FORZA Ti Spacer System implants are offered in two geometric shapes - straight and curved, and offered in parallel and lordotic profiles to restore the natural curvature of the spine. The implants can be used in single placement or in pairs. Both the curved and straight implants feature a bulleted nose for ease of insertion and a roughened surface on both the inferior and superior faces of the implant to provide increased stability and help prevent anterior/posterior movement of the device.

The FORZA Ti Spacer System is intended for intervertebral body fusion to aid in the surgical correction of the spine and are implanted using a posterior approach.

The FORZA Ti Spacer System is not intended to be used as a standalone device. The FORZA Ti Spacer System must be used with a supplemental fixation system.

The FORZA Ti Spacer System implants are provided sterile.

FORZA Ti implants are designed for use with FORZA PEEK and FORZA PTC Spacer System instrumentation. The FORZA Ti spacers are not compatible with components or metal from any other manufacturer's system.

FORZA XP Expandable Spacer System - The FORZA XP Expandable Spacer System is comprised of an assortment of non-sterile, single use, titanium allov (Ti-6AI-4V ELI per ASTM F136) and Polyetheretherketone (PEEK) Polymer (PEEK OPTIMA® LT1 per ASTM F2026) spacers with height expansion capability. The expandable interbody spacer is inserted into the lumbar disc space and expanded to fit the patient anatomy.

The implants are offered in parallel, lordotic, and hyperlordotic configurations to help restore the natural curvature of the spine. The implants can be used in single placement or pairs with typical approaches being transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF).

The implants feature a bulleted nose for ease of insertion ripples on both the inferior and superior surfaces to provide increased stability and help prevent anterior/posterior movement of the device.

The FORZA XP Expandable Spacer System is not intended to be used as a stand-alone device. The system must be used with a supplemental fixation system, is provided non-sterile and requires sterilization prior to use.

Lonestar Cervical Standalone System - The LONESTAR Cervical Stand Alone System is a stand-alone spacer system designed to provide biomechanical strength to a traditional or minimally invasive ACDF procedure with less disruption of patient anatomy and preservation of the anatomical profile. The system helps to preserve the natural sagittal anatomic profile of the cervical spine while providing anterior column support and stability.

The LONESTAR implant consists of a hybrid PEEK and titanium spacer along with titanium bone screws and a titanium cover plate. The spacers are designed with a zero degree anterior profile and are implanted using an anterior approach.

The LONESTAR Cervical Stand Alone implants and instruments are provided non-sterile and will require thorough cleaning and sterilization prior to each use. The implants are not compatible with components or metal from any other manufacturer's system.

PILLAR PEEK Spacer System - The PILLAR PEEK Spacer System is comprised of a variety of implants manufactured from PEEK (Polyetheretherketone) as described by ASTM F2026 with tantalum markers as described by ASTM F560. The implants are available in a variety of sizes and are offered in parallel and lordotic profiles in order to restore the natural curvature of the spine. The implants are available in various heights in either one or two millimeter increments. The superior and inferior surfaces of the implant have a pattern of ripples to provide increased stability and help prevent anterior/posterior movement of the device.

The PILLAR PEEK Spacer System is intended for intervertebral body fusion or partial vertebral body replacement to aid in the surgical correction and stabilization of the spine.

The PILLAR PEEK Spacer System is not intended to be used as a stand-alone device and must be used with supplemental fixation. The system is provided non-sterile and requires sterilization prior to use.

PILLAR SA PEEK Spacer System - The PILLAR SA PEEK Spacer System is comprised of a variety of implants manufactured from PEEK (Polyetheretherketone) as described by ASTM F2026 with tantalum markers as described by ASTM F560. The implants are available in multiple footprints, a variety of heights, and two angles of lordosis: 7° and 12°. The implants incorporate integrated anterior screw holes to allow for medial placement of screws, as well as a titanium plate for securing the screws once in place. The superior and inferior surfaces of the implant have a pattern of ripples that provide increased stability and help prevent of the device.

The PILLAR SA PEEK Spacer System is provided non-sterile.

PILLAR SA PTC Spacer System - The PILLAR SA PTC Spacer System is comprised of a variety of implants that have a PEEK core with integrated porous titanium end plates. The implants incorporate integrated anterior screw holes to allow for medial placement of bone screws as well as a titanium plate for securing the bone screws once in place. The implants are designed with a roughened surface on the inferior and superior faces of the implant to provide increased stability and help prevent anterior/posterior movement of the device.

The PILLAR SA PTC Spacer System is intended for intervertebral body fusion to aid in the surgical correction of the spine and is implanted using an anterior approach.

The PILLAR SA PTC spacers are provided sterile. The cover plate, screws and instruments are provided non-sterile and require sterilization prior to use.

The PILLAR SA PTC implants are designed to be used with PILLAR SA PEEK Spacer System instrumentation. The implants are not compatible with components from any other manufacturer's system.

SKYHAWK Lateral Interbody Fusion System - The SKYHAWK Lateral Interbody Fusion System consists of implants, trials, and instruments and is comprised of a variety of implants fabricated and manufactured from polyetheretherketone (PEEK) as described by ASTM F2026 with tantalum markers as described by ASTM F560. PEEK is utilized due to its radiolucent property, which aids the surgeon in determining if fusion in the operative site has occurred. Since PEEK is transparent in x-rays, tantalum marker pins are inserted into the implants in order to give surgeons a visual aid in determining the implants, both intraoperatively and postoperatively.

The SKYHAWK Lateral Interbody Fusion System implants are offered in parallel and lordotic profiles to restore the natural curvature of the spine; the device may be implanted using a lateral approach.

The SKYHAWK Lateral Interbody Fusion System implants, trials and instruments are provided non-sterile. They require sterilization prior to use.

The provided text is a 510(k) Summary for multiple spinal implant systems, focusing on the addition of "MR Conditional" labeling. It details the device descriptions and indications for use but does not contain information about acceptance criteria or a study proving clinical effectiveness or device performance in the context of typical medical device evaluation (e.g., diagnostic accuracy, treatment efficacy in patients).

Instead, the "performance data" section (page 26) pertains to the safety and compatibility of passive implants in the Magnetic Resonance (MR) Environment to support the MR Conditional labeling. This is a specific type of performance evaluation, not a general study proving the device meets clinical acceptance criteria for its primary function (spinal fusion).

Therefore, most of the requested information regarding acceptance criteria, patient sample sizes, expert ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, and training set information is not available in the provided document.

Here's a breakdown of what can be extracted or inferred:

1. A table of acceptance criteria and the reported device performance:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size: Not applicable. The "test set" here refers to the physical devices themselves used for MR compatibility testing, not patient data. The number of devices tested is not specified.
• Data Provenance: Not applicable, as this refers to laboratory testing of physical devices according to ASTM standards, not clinical patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. Ground truth, in the context of MR compatibility testing, is defined by the ASTM standards and the physical measurements performed, not by expert interpretation of clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. Adjudication is relevant for interpreting ambiguous clinical data, not for laboratory measurements of physical properties.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This document describes spinal implants, not an AI-assisted diagnostic or treatment system.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable. This document describes spinal implants, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For MR Conditional Labeling: Ground truth is established by the specified ASTM standards and physical measurements.
• For Clinical Efficacy (Spinal Fusion Devices): This information is not provided in the document. Clinical ground truth for spinal fusion devices would typically involve imaging (e.g., CT scans to assess fusion), patient reported outcomes, and potentially re-operation rates or other clinical endpoints from previous studies.

8. The sample size for the training set

• Not applicable. This document describes spinal implants, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

• Not applicable.

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Ascent POCT System: When intended to promote fusion of the cervical spine-cervico-thoracic junction (Occiput - T3), the Ascent POCT System is indicated for: · Degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); - · Spondylolisthesis; - · Fracture/dislocation; - · Spinal Stenosis; - · Atlanto-axial fracture with instability; - · Occipito-cervical dislocation' - · Tumors' - · Revision of previous cervical spine surgery. The occipital bone screws are limited to occipital fixation only. The use of the multi-axial screws is limited to placement in the upper thoracic spine (T1-T3) for the treatment of thoracic conditions only. They are not intended to be placed in the cervical spine. The lateral offset adapter is indicated for use in the upper thoracic spine (TI-T3). The hooks are intended to be placed from C1 to T3. The Songer Cables (titanum) System to be used with the Ascent POCT System allows for wire/cable attachment to the posterior cervical spine. The Ascent POCT System can also be linked to the Spinal Fixation System using the axial or parallel rod connector.

Centurion POCT System: The Centurion POCT System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1 - T3): traumatic spinal fraumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Centurion POCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The Centurion POCT System can also be linked to the Orthofix Spinal Fixation System using the Axial or Parallel Rod Connector.

Connector System: 1. When used with the Centurion POCT System or Ascent POCT System for Posterior Occipital-Cervical-Thoracic (Occ -T3) The Connector System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1 - T3): traumatic spinal fraumatic dislocations: instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Connector System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. 2. When used with the Firebird System/Phoenix MIS Spinal Fixation System or Spinal Fixation System (SFS) for Thoracic, Lumbar, and Sacral Spine Fixation (T1-S2/Ilium) The Connector System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation system (T1-S2/Ilium), or as an anterolateral fixation system (T8-L5), in the treatment of the following acute and chronic instabilities or deformities: 1. degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) - 2. spondylolisthesis, - 3. trauma (i.e., fracture or dislocation), - 4. spinal stenosis, - 5. deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), - 6. tumor, - 7. pseudoarthrosis, and - 8. failed previous fusion. When used for posterior pedicle screw fixation in pediatric patients, the Connector System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Pediation is limited to a posterior approach. The Connector System is intended to be used with autograft or allograft.

Spinal Fixation System (SFS): The Spinal Fixation System (SFS) is intended for non-cervical use in the spine. The Spinal Fixation System (SFS), when used for pedicle screw fixation, is intended only for patients: - · Having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; - · Who are receiving fusion using autogenous bone graft only; - · Who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and - · Who are having the device removed after the development of a solid fusion mass. The Spinal Fixation System (SFS), when used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: a) Degenerative spondylolistheses with objective evidence of neurologic impairment; b) Fracture; c) Dislocation; d) Scoliosis: e) Kyphosis; f) Spinal tumor; and g) Failed previous fusion (pseudarthrosis). The Spinal Fixation System (SFS), when used for anterolateral non-pedicle screw fixation to the non-cervical spine, is intended for the following indications: a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies); b) Spondylolistheses; c) Spinal stenosis; d) Spinal deformities (i.e., scoliosis, kyphosis, lordosis); e) Tumor: f) Pseudoarthrosis; g) Previous failed fusion; and h) Trauma (i.e., fracture or dislocation).

Firebird Spinal Fixation Systems: The Firebird Spinal Fixation Systems are intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion system (T1-S2/Ilium), or as an anterolateral fixation system (T8-L5), in the treatment of the following acute and chronic instabilities or deformities: 1. degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) - 2. spondylolisthesis, - 3. trauma (i.e., fracture or dislocation), - 4. spinal stenosis. - 5. deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), - 6. tumor. - 7. pseudoarthrosis, and - 8. failed previous fusion. When used for fixation to the ilium, the offset connectors of the Firebird Spinal Fixation System must be used in conjunction with pedicle screws placed at the S1 or S2 spinal level. The Firebird Spinal Fixation Systems components are used with certain components of the Spinal Fixation System (SFS), including rods, rod connectors and cross-connectors. When used for posterior pedicle screw fixation in pediatric patients, the Firebird Spinal Fixation Systems are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Pediatric pedicle screw fixation is limited to a posterior approach. The Firebird Spinal Fixation Systems are intended to be used with autograft or allograft. The Phoenix MIS Fixation System when used with the Firebird Systems is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery. The JANUS Midline Fixation Screw and the JANUS Fenestrated Screw when used with the Firebird Spinal Fixation Systems is indicated to provide the surgeon with an open, minimally invasive or midline approach for posterior spinal surgery. The JANUS Fenestrated Screws are intended to be used with saline and radiopaque dye.

FIREBIRD SI Fusion System: The FIREBIRD System is intended for fixation of sacroiliac joint disruptions, and intended for sacrolliac joint fusion for conditions including; · sacroiliac joint disruptions, · degenerative sacroiliitis, · to augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion and · Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.

Ascent POCT System - The Ascent POCT System is a temporary, multiple component system comprised of a variety of non-sterile, single use components made of titanium alloy or cobalt chrome alloy, that allow the surgeon to build a spinal implant construct. The Ascent POCT System consists of an assortment of rods, set screws, cross connectors, axial connectors, lateral offset adapters, multi-axial screws, hooks, plates, bone screws and songer cables. When used in the occipito-cervico-thoracic spine. the Ascent POCT System may be used from the Occiput to T3.

Centurion POCT System - The Centurion POCT System is a temporary, multiple component system comprised of a variety of non-sterile, single use components made of titanium allov or cobalt chrome alloy that allow the surgeon to build a spinal implant construct. The Centurion POCT System consists of an assortment of rods, set screws, axial connectors, lateral offset adapters, multi-axial screws, hooks, plates, bone screws, and cables (titanium).

Spinal Fixation System (SFS) - The Spinal Fixation System (SFS) is a temporary, titanium alloy, multiple component system comprised of a variety of non-sterile, single use components that allow the surgeon to build a spinal implant construct. The system is attached to the vertebral body by means of screws, and hooks to the non-cervical spine. The Spinal Fixation System consists of an assortment of screws, hooks, rods, spacers, staples, washers, dominos, lateral offsets, and cross-connectors. The Spinal Fixation System (SFS) titanium implants are not compatible with components or metal from any other manufacturer's system. The Spinal Fixation System (SFS) is intended for non-cervical use in the spine. When used as a nonpedicle anterolateral fixation system it may be used from levels T1 to S1. When used with pedicle screw fixation, the Spinal Fixation System (SFS) will be used at L5-S1, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 and below). When used as a posterior non-pedicle fixation system it may be used from levels T 1 to S1. When used as a non-pedicle anterolateral screw fixation system to the non-cervical spine, the staple and washer may be used from levels T6-L5.

Firebird Spinal Fixation Systems: (Firebird Deformity Spinal Fixation System, Phoenix MIS Spinal Fixation System, Phoenix CDX MIS Spinal Fixation System, JANUS Midline Fixation, Screws, Firebird NXG Spinal Fixation System, JANUS Fenestrated Screws)- The Firebird Spinal Fixation Systems include temporary, multiple component systems comprised of a variety of non-sterile and sterile single use components made of titanium alloy or cobalt chrome alloy that allow the surgeon to build a spinal implant construct. The systems are attached to the vertebral body and ilium by means of screw or hook fixation to the non-cervical spine. The systems consist of an assortment of rods, multi-axial and mono-axial pedicle screws, lateral offsets, bone screws, screw bodies, hooks, iliac connectors and sterile packed HA coated bone screws. A subset of the systems' components may be used in pediatric patients. These components consist of a variety of screws ranging in diameters from 4.0mm to 7.5mm and lengths ranging from 25mm to 60mm.

Connector System - The Connector System is designed to reduce the complexity of revising and extending existing constructs from the Occiput to the Ilium. The Connector System includes a variety of non-sterile implants manufactured from titanium alloy comprised of bypass connectors, rod to rod connectors, Z rods, and an axial in-line connector with an attached rod. The Connector System implant options offered eliminate the need to remove existing hardware while providing stability to adjacent levels. The Connector System is compatible with posterior spinal fixation systems (e.g. Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System. Spinal Fixation System, Centurion POCT System, and Ascent POCT System) which offer titanium and/or cobalt chrome rods ranging in sizes of 3.0mm to 6.35mm.

FIREBIRD SI Fusion System - The FIREBIRD SI Fusion System is a temporary, multiple component system consisting of non-sterile instruments as well as both non-sterile and sterile, cannulated screws of various lengths and diameters with multiple fenestrations on their shafts. The FIREBIRD SI Screws are constructed from medical- grade titanium alloy (Ti-6Al-4V ELI). The 11mm and 12mm FIREBIRD SI Screws are 3D printed with a mid-shaft porous region. The porous titanium region has open macroscopic 3D pores with a microscopic roughened surface. The FIREBIRD SI Screw allows for packing of autograft and allograft materials. FIREBIRD SI Fusion System consists of cannulated, fenestrated 9mm, 11mm, and 12mm diameter implants in lengths ranging from 25mm to 70mm. The 9mm diameter implant maintains a single pitch thread along the entire shaft of the 11mm diameter implant features a tapered proximal end and dual-pitch threads. The 12mm diameter implant maintains a single pitch thread form on the proximal and distal ends. The principle of operation is based on the bone screw implants which are designed to prevent and minimize motion / micro motion of the sacroiliac (SI) joint, and thereby stabilize the joint or fracture. The mechanism of action is that the interference fit allows for fixation, stabilization and fusion.

The provided text is a 510(k) summary for several spinal fixation systems. This document outlines the devices' intended use, technological characteristics, and performance data related to MR Conditional labeling. It does not contain information about AI/ML algorithm acceptance criteria or studies proving device performance based on AI/ML.

Therefore, I cannot extract the requested information regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
6. If a standalone (algorithm only) performance was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

This document focuses on the mechanical and material safety of the spinal implants in an MRI environment, not on the performance of a diagnostic or assistive AI/ML algorithm.

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The FIREBIRD SI Fusion System is intended for fixation of sacroiliac joint disruptions, and intended for sacroiliac joint fusion for conditions including;

· sacroiliac joint disruptions,

· degenerative sacroiliitis,

· to augment immobilization and stabilization of the sacroillac joint in skeletally mature patients undergoing sacropelvic

fixation as part of a lumbar or thoracolumbar fusion and

• Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.

The FIREBIRD SI Fusion System is a temporary, multiple component system consisting of non-sterile instruments as well as both non-sterile, cannulated screws of various lengths and diameters with multiple fenestrations on their shafts. The FIREBIRD SI Screws are constructed from medical- grade titanium alloy (Ti-6Al-4V ELI). The 11mm and 12mm FIREBIRD SI Screws are 3D printed with a mid-shaft porous region. The porous titanium region has open macroscopic 3D pores with a microscopic roughened surface. The FIREBIRD SI Screw allows for packing of autograft and allograft materials.

FIREBIRD SI Fusion System consists of cannulated, fenestrated 9mm, 11mm, and 12mm diameter implants in lengths ranging from 25mm to 70mm. The 9mm diameter implant maintains a single pitch thread along the entire shaft of the 11mm diameter implant features a tapered proximal end and dual-pitch threads. The 12mm diameter implant maintains a single pitch thread form on the proximal and distal ends.

The principle of operation is based on the bone screw implants which are designed to prevent and minimize motion / micro motion of the sacroiliac (SI) joint, and thereby stabilize the joint or fracture. The mechanism of action is that the interference fit allows for fixation, stabilization and fusion.

The provided text is a 510(k) summary for the FIREBIRD SI Fusion System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's performance against specific acceptance criteria.

The 510(k) summary states that the device is identical to a previously cleared device, and therefore, its performance characteristics are the same. It does not contain a study proving the device meets new acceptance criteria. Instead, it relies on the predicate device's prior clearance to establish equivalence.

Therefore, I cannot provide the requested information from the given text as it does not contain a standalone study with acceptance criteria and reported device performance.

Here's why and what information is available:

• No Acceptance Criteria or Reported Device Performance: The document explicitly states, "The performance and technological characteristics of the subject device are unchanged as the subject 9mm FIREBIRD SI Screw is identical to the predicate FIREBIRD SI Fusion System 9mm FIREBIRD SI Screw (K203138) in terms of design, materials and performance characteristics." This means Orthofix is not presenting new performance data for this submission; they are asserting that its performance is equivalent to the predicate.
• No Test Set/Ground Truth Information: Since no new performance study is detailed, there's no information on sample size, data provenance, expert ground truth establishment, or adjudication methods for a test set.
• No MRMC or Standalone Performance Study: The document doesn't describe any studies involving human readers with or without AI assistance, nor does it detail a standalone algorithm performance study. This is expected as the device is a physical bone fixation system, not an AI/software device.
• No Training Set Information: Without a new performance study, there's no mention of a training set or how its ground truth would be established.

The core of this 510(k) submission is to demonstrate that the new version of the FIREBIRD SI Fusion System (specifically, the sterile-packaged 9mm screws) is substantially equivalent to an already cleared version. It relies on the prior approval and testing of the predicate device.

To answer your request, here's what the document does provide, although it doesn't directly address "acceptance criteria and a study that proves the device meets them" for this specific submission:

1. A table of acceptance criteria and the reported device performance:
Not available in the document. The document asserts equivalence to a predicate device, implying its performance is already known and accepted from the predicate's clearance.

2. Sample sized used for the test set and the data provenance:
Not available in the document. No new test set described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not available in the document. No new ground truth establishment described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not available in the document. No new test set described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No, this is not applicable. The device is a physical bone fixation screw system, not an AI/imaging device that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No, this is not applicable. The device is a physical bone fixation screw system, not an algorithm.

7. The type of ground truth used:
Not applicable. No new ground truth described for this submission. The basis for clearance is substantial equivalence to a predicate device, which would have undergone its own testing based on engineering standards and clinical data for its intended use.

8. The sample size for the training set:
Not applicable. No training set is mentioned as this is not an algorithm-based device.

9. How the ground truth for the training set was established:
Not applicable. No training set is mentioned.

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The CONSTRUX Mini Ti Spacer System is indicated for spinal fusion procedures at one or two contiguous levels within the cervical spine (C2-T1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.

The CONSTRUX Mini Ti Spacer System is intended for use with autograft comprised of cancellous and/ or corticocancellous bone graft and supplemental fixation system; the hyperlordotic implants (≥10°) are required to be used with an anterior cervical plate.

Patients must have undergone a regimen of at least six weeks of non-operative treatment prior to being treated with the CONSTRUX Mini Ti Spacer System in the cervical spine.

The CONSTRUX Mini Ti Spacer System is comprised of a variety of 3D printed implants that have porous titanium end plates and a functional gradient porous structure. CONSTRUX Mini Ti spacers are implanted in the cervical intervertebral disc space and are intended to facilitate vertebral fusion by stabilizing adjacent vertebrae, maintaining disc height and preventing the collapse of one vertebra onto another.

The CONSTRUX Mini Ti Spacer System is not intended to be used as a stand-alone device and must be used with supplemental fixation. The implants are used singly and are implanted using an anterior approach. The CONSTRUX Mini Ti implants are provided sterile.

The information provided describes the acceptance criteria and the study for the CONSTRUX Mini Ti Spacer System, a medical device, not an AI/ML powered device. Therefore, many of the typical AI/ML study questions, such as sample sizes for test and training sets, expert qualifications for ground truth, adjudication methods, MRMC studies, and standalone performance, are not applicable.

Here's a summary of the available information regarding the device's acceptance criteria and the study proving it meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

For the CONSTRUX Mini Ti Spacer System, the "acceptance criteria" are implied by the mechanical testing standards, and the "reported device performance" is that the device met these standards and was found substantially equivalent to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

The provided text describes mechanical testing performed according to specified ASTM standards. These standards dictate the number of test specimens (samples) required for each test. However, the exact sample sizes used for each specific test (e.g., how many devices were subjected to static axial compression) are not explicitly stated in this document.

The "data provenance" is typically the results of in-vitro mechanical testing performed by the manufacturer, Orthofix Inc. This is not clinical data, so terms like "country of origin" or "retrospective/prospective" are not applicable in this context.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This question is not applicable. For mechanical testing of medical devices, "ground truth" is established by the specifications and methodologies outlined in the ASTM standards themselves, and the measurements are taken by testing equipment and qualified technicians/engineers. There is no expert consensus involved in establishing ground truth for mechanical test results in this manner.

4. Adjudication Method for the Test Set

This question is not applicable as the "test set" refers to mechanical testing, not a clinical study involving human assessment that would require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This question is not applicable as the device is a spinal implant, not an AI/ML-powered diagnostic or assistive tool for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the device is a spinal implant, not an algorithm.

7. The Type of Ground Truth Used

For the mechanical performance testing, the "ground truth" relies on:

• ASTM standards: The established methodologies and acceptance criteria defined within ASTM F2077, ASTM F2267, and ASTM F1877.
• Physical measurements: The quantitative results obtained from the mechanical tests (e.g., force, displacement, wear).

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical medical implant, not an AI/ML model that undergoes a "training" phase.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the same reason as point 8.

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The FORZA Ti Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade I spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved levels.

The FORZA Ti Spacer System is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation system.

Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the FORZA Ti Spacer System.

FORZA Ti Spacer System is comprised of a variety of 3D Titanium printed implants (conforming to ASTM F3001) that have porous end plates and a functional gradient porous structure. The implant superior and inferior Titanium plate surface provides increased stability for the implant. The titanium porous structure have open macroscopic 3D pores with a microscopic roughened surface and nano-scale features. FORZA Ti Spacer System is implanted in the intervertebral disc space and is intended to facilitate vertebral fusion by stabilizing adjacent vertebrae, maintaining disc height, and preventing the collapsing of one vertebrate onto another.

FORZA Ti Spacer System is not intended to be used as a stand-alone device and must be used with supplemental fixation. FORZA Ti implants are provided sterile.

The Orthofix FORZA® Ti Spacer System is an intervertebral body fusion device. Based on the provided FDA 510(k) summary, the device's acceptance criteria and the study proving it meets these criteria are described below:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of clinical trial data provenance (e.g., country of origin, retrospective/prospective) for this device. The evaluation of this device for 510(k) clearance was based on mechanical testing, not clinical data from patients. Therefore, the "sample size" refers to the number of devices or materials tested during these mechanical evaluations. The exact number of units tested for each specific mechanical test (ASTM F2077, F2267, F1877) is not explicitly stated in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable. The device's evaluation was based on mechanical engineering standards (ASTM) for performance testing, not on human expert interpretation of clinical images or patient data to establish ground truth.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods are typically used in clinical studies where expert consensus is needed to resolve discrepancies in image interpretation or clinical diagnosis. This device was evaluated through mechanical testing against established engineering standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. The device is a surgical implant (intervertebral body fusion device), not an imaging or diagnostic AI tool. Therefore, MRMC studies and "human readers improving with AI" are irrelevant to its evaluation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. The device is a physical implant, not an algorithm.

7. The type of ground truth used

The "ground truth" for the device's performance was established by recognized engineering and materials standards (ASTM F2077, ASTM F2267, ASTM F1877). Successful adherence to these standards, and demonstration of substantial equivalence to a predicate device that also meets these standards, constitutes the "ground truth" for its safety and effectiveness in its intended mechanical function.

8. The sample size for the training set

This information is not applicable. This device is not an AI algorithm and does not involve a training set in the machine learning sense. The tests are mechanical evaluations of the physical product.

9. How the ground truth for the training set was established

This information is not applicable for the same reason as above.

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The FIREBIRD SI Fusion System is intended for fixation of sacroiliac joint disruptions, and intended for sacroiliac joint fusion for conditions including:

• sacroiliac joint disruptions, ●
• degenerative sacroiliitis, ●
• to augment immobilization and stabilization of the sacroiliac ioint in skeletally mature . patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion and
• Acute, non-acute, and non-traumatic fractures involving the sacroillac ioint. ●

The FIREBIRD SI Fusion System is a temporary multiple component system consisting of nonsterile instruments, sterile 11mm and 12mm FIREBIRD SI Screws and non-sterile 9mm FIREBIRD SI Screws. The FIREBIRD SI Screws are manufactured from medical-grade titanium alloy (Ti-6Al-4V ELI) with lengths ranging from 25mm to 70mm.

The 11mm FIREBIRD SI Screw is a cannulated screw featuring multiple fenestrations along the shaft, with a tapered proximal end and dual-pitch threads. The 12mm FIREBIRD SI Scew is a cannulated screw featuring multiple fenestrations along the shaft, with a single pitch thread on the proximal and distal ends. The 11mm and 12mm FIREBIRD SI Screws are 3D printed with a mid-shaft porous region. The porous titanium region has open macroscopic 3D pores with a microscopic roughened surface. The 9mm FIREBIRD SI Screw features multiple fenestrations along the shaft and maintains a single pitch thread along the proximal and distal ends of the screw.

The FIREBIRD SI Fusion System allows for packing of autograft and allograft materials.

The principle of operation is based on the bone screw implants which are designed to prevent and minimize motion / micro motion of the sacroiliac (SI) joint, and thereby stabilize the joint or fracture. The mechanism of action is that the interference fit allows for fixation, stabilization and fusion.

The provided text is a 510(k) summary for the FIREBIRD SI Fusion System. It states that there are no changes to the technological characteristics, intended use, or overall risks associated with the device compared to its predicate device. Therefore, no new design verification or validation testing was required for this particular submission. The summary explicitly states that the previous testing performed for earlier 510(k) clearances (K201664, K200696, and K183342) is applicable.

This means the document does not contain the information requested regarding acceptance criteria and study details for the current K203138 submission because new studies were not conducted. It refers to previous clearances.

To answer your request, I would need access to the 510(k) summaries or supporting documentation for the predicate devices mentioned, specifically:

• K201664 - Orthofix Inc. - FIREBIRD SI Fusion System (Primary Predicate)
• K200696 (Mentioned as having applicable testing)
• K183342 (Mentioned as having applicable testing)

Without access to those specific documents, I cannot provide the detailed acceptance criteria and study information you've requested.

However, based on the provided text, I can state the following:

1. A table of acceptance criteria and the reported device performance

• Not provided in this document. The document states "no new design verification or validation testing was required" for this submission (K203138). It refers to previous 510(k)s for relevant data.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not provided in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not provided in this document. This device is a bone fixation system, not an AI or diagnostic imaging device that typically requires expert-established ground truth for performance evaluation in the way you're describing. Its testing would involve mechanical and biocompatibility assessments, not clinical interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not provided in this document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable/Not provided in this document. This device is a physical implant, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable/Not provided in this document.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable/Not provided in this document for the reasons stated above (physical implant, not an AI/diagnostic device). "Ground truth" for this type of device would typically relate to mechanical properties (e.g., strength, fatigue life) matching specific standards or predicate performance, and biocompatibility.

8. The sample size for the training set

• Not applicable/Not provided in this document. No AI training set is relevant for this physical device.

9. How the ground truth for the training set was established

• Not applicable/Not provided in this document.

In summary: The provided document is a 510(k) summary for a physical medical device (bone fixation system). It leverages previous clearances for its substantial equivalence argument, stating that no new testing was required for this specific submission (K203138) because the device's technological characteristics, intended use, and risks are unchanged from its predicates. The questions you've posed (especially those about AI, readers, ground truth establishment, training sets) are highly relevant for AI/Software as a Medical Device (SaMD), but generally are not directly applicable to the type of device described in this 510(k) (a physical implantable screw system).

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When used as a cervical intervertebral body fusion device, the CONSTRUX Mini PEEK Spacer System is indicated for spinal fusion procedures at one or two contiguous levels within the cervical spine (C2-T1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.

The CONSTRUX Mini PEEK Spacer System is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation system; the hyperlordotic implants (≥10°) are required to be used with an anterior cervical plate.

Patients must have undergone a regimen of at least six weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PTC Spacer System in the cervical spine.

When used as a Partial Vertebral Body Replacement (VBR) System, the CONSTRUX Minn PEEK Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The CONSTRUX Mini PEEK Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. Lordotic implants greater than a 5° profile are not to be used for partial vertebral body replacement.

The CONSTRUX Mini PEEK Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. The Partial VBR device is intended to be used with autograft or allograft and supplemental fixation system.

The CONSTRUX Mini PTC Spacer System is comprised of a variety of implants manufactured from PEEK (Polyetheretherketone), as described by ASTM F2026, with titanium markers as described by ASTM F67. The implants are available in multiple sizes to accommodate various patient anatomies. The superior and inferior surfaces of the implant have a pattern of ripples to provide increased stability and help prevent anterior/posterior movement of the device.

The CONSTRUX Mini PEEK Spacer System is not intended to be used as a standalone device. The CONSTRUX Mini PEEK Spacer System must be used with a supplemental fixation system.

The provided document is a 510(k) Premarket Notification from the FDA for the CONSTRUX Mini PEEK Spacer System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through extensive clinical trials with an explicit set of acceptance criteria based on device performance in human subjects.

Therefore, the document does not contain the information requested in points 1-9 regarding a study that proves the device meets specific acceptance criteria related to its performance in a clinical setting (e.g., accuracy, diagnostic performance, or human reader improvement with AI assistance).

The "Performance Testing Summary" section indicates that the device was evaluated via mechanical testing (ASTM F2077 and ASTM F2267) to demonstrate substantial equivalence, not clinical performance. These tests assess the physical properties and structural integrity of the implant.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance related to a clinical study.
2. Sample sizes for a test set, data provenance, or details about the retrospective or prospective nature of data.
3. Number or qualifications of experts used to establish ground truth for a test set.
4. Adjudication methods for a test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes for human readers.
6. Results of a standalone algorithm-only performance study.
7. The type of ground truth used (expert consensus, pathology, outcomes data) for clinical evaluation.
8. Sample size for a training set (as this is not an AI/ML device that requires distinct training and test sets in the traditional sense).
9. How ground truth for a training set was established.

This 510(k) submission primarily relies on bench testing and comparison against predicate devices to establish substantial equivalence for market clearance, rather than the kind of clinical performance study details requested in your prompt.

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The CONSTRUX® Mini PTC Spacer System is indicated for spinal fusion procedures at one or two contiguous levels within the cervical spine (C2-T1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.

The CONSTRUX Mini PTC Spacer System is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation system; the hyperlordotic implants (≥10°) are required to be used with an anterior cervical plate.

Patients must have undergone a regimen of at least six weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PTC Spacer System in the cervical spine.

The CONSTRUX Mini PTC Spacer System is comprised of a variety of implants that has a PEEK core (conforming to ASTM F2026) with integrated porous Titanium alloy (Ti-6Al-4V) endplates (conforming to ASTM F1580). The implant superior and inferior Titanium plate surface provides increased stability for the implant. The titanium endplates have open macroscopic 3D pores with a microscopic roughened surface and nano-scale features. The CONSTRUX Mini PTC spacer is implanted in the cervical intervertebral disc space and is intended to facilitate vertebral fusion by stabilizing adjacent vertebrae, maintaining disc height, and preventing the collapsing of one vertebrate onto another.

The CONSTRUX Mini PTC Spacer System is not intended to be used as a standalone device. The CONSTRUX Mini PTC Spacer System must be used with a supplemental fixation system. The CONSTRUX Mini PTC Spacer System implants are provided sterile.

This document is an FDA 510(k) clearance letter for a medical device called the "CONSTRUX® Mini PTC Spacer System." It is a regulatory approval document and does not contain information about the acceptance criteria or a study proving the device meets those criteria from an AI/performance perspective.

The "Performance Testing Summary" explicitly states: "No new mechanical testing was performed for the CONSTRUX Mini PTC Spacer System because the 10° lordosis does not create a new worst case construct for mechanical performance."

Therefore, based solely on the provided text, I cannot answer the questions about acceptance criteria for device performance, especially those related to AI or clinical study performance. The document focuses on establishing substantial equivalence to existing predicate devices based on design, materials, and intended use, rather than presenting a performance study against specific acceptance criteria.

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The FIREBIRD SI Fusion System is intended for fixation of sacroiliac joint disruptions, and intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The FIREBIRD SI Fusion System (formally SambaScrew 3D SI Fusion System) is a temporary multiple component system consisting of non-sterile instruments, sterile 11mm and 12mm FIREBIRD SI Screws and non-sterile 9mm FIREBIRD SI Screws. The FIREBIRD SI Screws are manufactured from medical-grade titanium alloy (Ti-6AI-4V ELI) with lengths ranging from 25mm to 70mm.

The 11mm FIREBIRD SI Screw is a cannulated screw featuring multiple fenestrations along the shaft, with a tapered proximal end and dual-pitch threads. The 12mm FIREBIRD SI Scew is a cannulated screw featuring multiple fenestrations along the shaft, with a single pitch thread on the proximal and distal ends. The 11mm and 12mm FIREBIRD SI Screws are 3D printed with a mid-shaft porous region. The porous titanium region has open macroscopic 3D pores with a microscopic roughened surface. The 9mm FIREBIRD SI Screw features multiple fenestrations along the shaft and maintains a single pitch thread along the proximal and distal ends of the screw.

The FIREBIRD SI Fusion System allows for packing of autograft and allograft materials.

This document is a 510(k) premarket notification for the Orthofix FIREBIRD SI Fusion System. It primarily addresses the addition of nano-scale descriptors to the device labeling and explicitly states that the device's technological characteristics, performance data, and other critical aspects remain unchanged since its prior clearance (K200696). Therefore, there is no new study or new acceptance criteria presented in this document for the FIREBIRD SI Fusion System itself.

The document refers to studies from a predicate device (K200052 – Orthofix Inc. – PTC Systems) to support the nano-surface descriptors. These studies focused on surface characterization and in vitro cellular studies to demonstrate increased proliferation and alkaline phosphatase activity in human stem cells with the PTC modified surface.

Since the core device is unchanged and no new performance studies for the FIREBIRD SI Fusion System are detailed in this 510(k) submission, a table of acceptance criteria and reported device performance directly from this document cannot be created for the FIREBIRD SI Fusion System in the way requested. Instead, I will summarize the information provided regarding the reliance on prior clearances and the nature of the supporting data for the nano-surface descriptors.

Summary regarding Acceptance Criteria and Study for FIREBIRD SI Fusion System (K201664):

This 510(k) submission (K201664) for the FIREBIRD SI Fusion System does not introduce new acceptance criteria for the device's overall function or new studies to demonstrate its performance. The submission's purpose is to add nano-scale descriptors to the labeling.

The document explicitly states:

• "The technological characteristics of the FIREBIRD SI Fusion System are unchanged since the prior clearance K200696."
• "The performance data of the FIREBIRD SI Fusion System are unchanged since the prior clearance K200696. No new mechanical testing was performed for the FIREBIRD SI Fusion System as there are no design changes to the device."
• "The previously cleared indications for use, intended use, design, specifications, contraindications, warnings or precautions remain the same as previously cleared under K200696."

Therefore, the acceptance criteria and supporting studies for the overall device performance would be found in the K200696 submission.

However, the submission does refer to data used to support the nano-surface descriptors, which were previously cleared under predicate K200052. The details on this specific aspect are provided below, but it's important to note these studies are not for the overall performance of the FIREBIRD SI Fusion System as a fusion device, but rather for a specific material characteristic.

1. Table of acceptance criteria and the reported device performance

As no new performance data or acceptance criteria are presented for the FIREBIRD SI Fusion System in this 510(k) submission (K201664), a direct table cannot be provided. The submission relies on prior clearances.

However, regarding the nano-surface descriptors, which is the focus of this particular 510(k) (K201664):

Note: These are derived from the limited information provided in K201664, which heavily references prior 510(k)s (K200696 for the device itself and K200052 for the nano-surface technology). Full details would be in those respective submissions.

Supporting Information for the nano-surface descriptors (based on referenced K200052):

2. Sample size used for the test set and the data provenance:

• Sample Size (Test Set): Not specified in this document. It refers to "in vitro cellular studies using HMSCs and normal human osteoblasts (NHOst) cells." The number of cells, replicates, or experiments is not detailed.
• Data Provenance: In vitro cellular studies. Country of origin not specified, but typically lab-based studies for medical device material properties are conducted by the manufacturer or a contract research organization. Retrospective or prospective is not applicable as it's a lab study, not human subject data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Experts: Not applicable for in vitro cellular studies. The "ground truth" for such studies would be the objective measurements of cellular activity (proliferation, enzyme activity) quantified by laboratory equipment and interpreted by scientific personnel.

4. Adjudication method for the test set:

• Adjudication Method: Not applicable for in vitro cellular studies. Data would be analyzed statistically, and results would be based on predefined scientific protocols and statistical significance.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• MRMC Study: No. This is an orthopedic implant for physical fixation and fusion, supported by mechanical and in vitro cellular studies. It is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Standalone Performance: Not applicable. This is an implanted medical device, not a software algorithm.

7. The type of ground truth used:

• Ground Truth: For the in vitro cellular studies referenced (from K200052), the "ground truth" would be the quantified biological responses of human stem cells and osteoblasts (e.g., cell counts for proliferation, enzymatic assay readings for alkaline phosphatase activity).

8. The sample size for the training set:

• Training Set Sample Size: Not applicable. This is an experimental study for material characterization and biological response, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established:

• Ground Truth for Training Set Establishment: Not applicable, as there is no training set mentioned.

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